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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name prostate lesion, documentation, system
De Novo Number DEN100016
510(K) Number K093579
Device Name PROSTATE MECHANICAL IMAGER
Requester
artann laboratories, inc
555 13th street nw
columbia square
washington,  DC  20004
Contact gerard j prud'homme
Regulation Number876.2050
Classification Product Code
OQT  
Date Received05/21/2010
Decision Date 04/27/2012
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
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